Diet, HealthyMTM4CVHNCT06550297
Medically Tailored Meals for Cardiovascular Health
A study testing Medically Tailored Meals and Nutritional Counseling and Cardiovascular Health Promotion Educational Program in people with Diet, Healthy and HbA1c, run by Columbia University at 1 site in United States.
Trial summary
This randomized clinical trial (RCT) will investigate novel approaches to enhance effectiveness, engagement, reach, and cost-effectiveness of medically tailored meals (MTM) programs for promoting cardiovascular health, focusing on economically disadvantaged New York City neighborhoods with a disparate burden of… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Diet, Healthy, HbA1c, Blood Pressure
- What is being tested?
- Medically Tailored Meals and Nutritional Counseling and Cardiovascular Health Promotion Educational Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Aug 2024to 5 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Qualifying type 2 diabetes diagnosis (typically physician referred to the program due to more advanced disease with uncontrolled diabetes and complications)
- Hypertension diagnosis (systolic blood pressure greater than or equal to 130 mmHg and/or diastolic blood pressure greater than or equal to 80 mmHg) or elevated blood pressure (defined as systolic blood pressure greater than or equal to 120 mmHg)
- Type 2 diabetes diagnosis (physician diagnosed or HbA1c greater than or equal to 6.5% or diabetes medication use)
- Hypertension diagnosis (systolic blood pressure greater than or equal to 130 mmHg and/or diastolic blood pressure greater than or equal to 80 mmHg or physician diagnosis or hypertension medication use) or elevated blood pressure (defined as systolic blood pressure greater than or equal to 120 mmHg)
Who cannot join
- Cancer diagnosis
- Undergoing cancer treatment
- Non-English or non-Spanish speaking
- Not cognitively able to complete study requirements
- Severe psychiatric disorders
- Inability to provide informed consent
Show all 15Show fewer
- Health conditions that could prevent safe participation or impact study outcomes (e.g., substance use disorder, dialysis, neurodegenerative conditions)
- For Cohort B (Individuals who do not currently qualify for MTMs)
- Cancer diagnosis
- Undergoing cancer treatment
- Non-English or non-Spanish speaking
- Not cognitively able to complete study requirements
- Severe psychiatric disorders
- Inability to provide informed consent
- Health conditions that could prevent safe participation or impact study outcomes (e.g., substance use disorder, dialysis, neurodegenerative conditions)
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Mailman School of Public Health
New York, New York, 10032
About this study
Official title: Enhancing, Culturally Adapting, and Expanding Medically Tailored Meals Programs to Address Cardiometabolic Multi-morbidity
This randomized clinical trial (RCT) will investigate novel approaches to enhance effectiveness, engagement, reach, and cost-effectiveness of medically tailored meals (MTM) programs for promoting cardiovascular health, focusing on economically disadvantaged New York City neighborhoods with a disparate burden of multiple cardiometabolic diseases. The main questions the RCT aims to answer are:
- Does enhancing MTM programs, with culturally relevant cardiovascular health curriculum (including educational sessions on heart health, healthy diet, cooking demonstrations, recipes, gift bags with healthy ingredients and fresh produce, and addressing social needs) enhance program engagement and effectiveness in improving short-term healthy eating behaviors and clinical outcomes (HbA1c and blood pressure) among individuals with type 2 diabetes and elevated to high blood pressure who currently qualify for MTM programs?
- Is the MTM program coupled with the cardiovascular health curriculum effective for improving healthy eating behaviors and clinical outcomes (HbA1c and blood pressure) among individuals with type 2 diabetes and elevated to high blood pressure who do not currently qualify for MTM programs and is a gradual reduction of MTM dosing an effective and sustainable approach for expanding reach of these programs?
Read more
To answer question 1, 66 participants with type 2 diabetes and elevated to high blood pressure who currently qualify for MTM programs will be randomized into a group that receives the standard MTM program (10 MTMs/week for 8 months) or a group that receives the standard program plus the cardiovascular health curriculum.
To answer question 2, 110 participants with type 2 diabetes and elevated to high blood pressure who do not currently qualify for MTM programs (due to not having advanced disease with complications) will be randomized into a group that receives the standard MTM program (10 MTMs/week for 8 months) plus the cardiovascular health curriculum or a group that receives standard MTM program for the first 3 months followed by a gradual reduction in dosing of the MTMs by 50% over the remaining 5 months plus the CVH curriculum.
All participants will have their HbA1c and blood pressure measured and complete questionnaires about their diet quality, health and lifestyle behaviors, and program engagement and implementation at baseline, 3 months, and 8 months.
Read the detailed description
Medically tailored meals (MTMs) represent an integral in-kind intervention of the Food Is Medicine (FIM) initiative aimed at providing healthy food in a way that is integrated with the health care sector to prevent and manage chronic disease. MTMs are a promising approach to address diet-related cardiovascular inequities, because they collectively address food and nutrition insecurity, severe illness or chronic cardiometabolic disease, and challenges with activities of daily living such as shopping for or preparing meals in those with complex medical conditions. However, additional research is needed to determine how MTM programs could be enhanced to become more culturally and contextually responsive, increase engagement with these programs, enhance their effectiveness and sustainability, and expand their reach.
- Conditions
- Diet, Healthy, HbA1c, Blood Pressure
- Being tested
- Medically Tailored Meals and Nutritional Counseling, Cardiovascular Health Promotion Educational Program
- Keywords
- Medically Tailored Meals, Type 2 Diabetes, High Blood Pressure, Multiple Cardiometabolic Morbidity, Food is Medicine
- Medical subject headings
- Diabetes Mellitus, Type 2, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medically Tailored Meals and Nutritional CounselingBehavioural
God's Love We Deliver's current MTM program, which consists of weekly home-delivered MTMs and nutritional counseling by a Registered Dietitian Nutritionist for an 8-month period. The Food is Medicine Coalition Clinical Committee establishes and regularly updates the MTM Nutrition Standards, which catalogue the nutrition quality of this evidence-based intervention. Arms 1-3 will receive 10 MTMs per week for 8 months. Arm 4 will receive a distinct dosing down approach as follows: 10 MTMs/week in months 1-3, 9 MTMs/week in month 4, 8 MTMs/week in month 5, 7 MTMs/week in month 6, 6 MTMs/week in month 7, and 5 MTMs/week in month 8.
Cardiovascular Health Promotion Educational ProgramBehavioural
Culturally and contextually tailored cardiovascular health promotion program that consists of didactic sessions focused on lifestyle change and the American Heart Association's Life's Essential 8 framework, setting weekly specific, measurable, attainable, realistic, and timely (S.M.A.R.T.) goals for health behavior modification, group coaching, cooking demonstrations, recipes and gift bags with healthy ingredients and fresh produce, and addressing social needs.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Cohort A (type 2 diabetes patients who currently qualify for MTMs) Active Comparator | Active comparator | Participants in this arm are type 2 diabetes patients with hypertension or elevated blood pressure who currently qualify for medically tailored meals (MTMs). This arm will receive God's Love We Deliver's current MTM program, which consists of 10 home-delivered MTMs per week and nutritional counseling by a Registered Dietitian Nutritionist for an 8-month period. Receives: Behavioral: Medically Tailored Meals and Nutritional Counseling |
| Arm 2: Cohort A (type 2 diabetes patients who currently qualify for MTMs) Intervention | Experimental | Participants in this arm are type 2 diabetes patients with hypertension or elevated blood pressure who currently qualify for medically tailored meals (MTMs). This arm will receive God's Love We Deliver's current MTM program, which consists of 10 home-delivered MTMs per week and nutritional counseling by a Registered Dietitian Nutritionist for an 8-month period (same as Arm 1). In addition, they will receive a culturally and contextually tailored cardiovascular health promotion program that consists of didactic sessions focused on lifestyle change and the American Heart Association's Life's Essential 8 framework, setting weekly specific, measurable, attainable, realistic, and timely (S.M.A.R.T.) goals for health behavior modification, group coaching, cooking demonstrations, recipes and gift bags with healthy ingredients, and addressing social needs. Receives: Behavioral: Medically Tailored Meals and Nutritional Counseling; Behavioral: Cardiovascular Health Promotion Educational Program |
| Arm 3: Cohort B (type 2 diabetes patients who do not currently qualify for MTMs) Active Comparator | Active comparator | Participants in this arm are type 2 diabetes patients with hypertension or elevated blood pressure who do not currently qualify for medically tailored meals (MTM) programs. This arm will receive God's Love We Deliver's current MTM program, which consists of 10 home-delivered MTMs per week and nutritional counseling by a Registered Dietitian Nutritionist for an 8-month period. In addition, they will receive a culturally and contextually tailored cardiovascular health promotion program that consists of didactic sessions focused on lifestyle change and the American Heart Association's Life's Essential 8 framework, setting weekly specific, measurable, attainable, realistic, and timely (S.M.A.R.T.) goals for health behavior modification, group coaching, cooking demonstrations, recipes and gift bags with healthy ingredients, and addressing social needs. Receives: Behavioral: Medically Tailored Meals and Nutritional Counseling; Behavioral: Cardiovascular Health Promotion Educational Program |
| Arm 4: Cohort B (type 2 diabetes patients who do not currently qualify for MTMs) Intervention | Experimental | Participants in this arm are type 2 diabetes patients with hypertension or elevated blood pressure who do not currently qualify for medically tailored meals (MTM) programs. This arm will receive the MTM program and nutritional counseling by a Registered Dietitian Nutritionist for an 8-month period but with a distinct MTM dosing schedule. They will receive the regular MTM schedule of 10 MTMs/week for the first 3 months of the intervention. After this initial period, MTM dosing will be gradually reduced by 1 MTM each month to a target schedule of 5 MTMs/week in the final month of the intervention. In addition, they will also receive the same culturally and contextually tailored cardiovascular health promotion program as Arms 2 and 3. Receives: Behavioral: Medically Tailored Meals and Nutritional Counseling; Behavioral: Cardiovascular Health Promotion Educational Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Diet Quality
The Mediterranean Eating Pattern for Americans (MEPA) scale, which captures adherence to a heart healthy dietary pattern, will be used to assess diet quality. The MEPA score ranges from 0-16 with higher scores indicating better diet quality. The change in MEPA scores from baseline to 8 months will be calculated and compared across randomization arms (comparing Arm 1 vs. Arm 2 and Arm 3 vs. Arm 4).
Measured: baseline, 3 months, 8 months (primary endpoint)
Change in HbA1c
A fast and accurate HbA1c fingerstick test will assess changes in glycemic control from baseline to 3 months and 8 months (comparing Arm 1 vs. Arm 2 and Arm 3 vs. Arm 4).
Measured: baseline, 3 months, 8 months (primary endpoint)
Change in systolic blood pressure
The change office systolic blood pressure (mmHg) from baseline to follow-up at 3 months and 8 months will be calculated and compared across randomization arms (comparing Arm 1 vs. Arm 2 and Arm 3 vs. Arm 4).
Measured: baseline, 3 months, 8 months (primary endpoint)
Secondary outcomes (14)
Mean Diet Quality
The Mediterranean Eating Pattern for Americans (MEPA) scale, which captures adherence to a heart healthy dietary pattern, will be used to assess diet quality. The MEPA score ranges from 0-16 with higher scores indicating better diet quality. The mean MEPA scores at 3 months will be calculated and compared across randomization arms (comparing Arm 1 vs. Arm 2 and Arm 3 vs. Arm 4).
Measured: baseline, 3 months, 8 months
Mean HbA1c
A fast and accurate HbA1c fingerstick test will assess glycemic control and mean HbA1c will be compared at 3 months and 8 months (comparing Arm 1 vs. Arm 2 and Arm 3 vs. Arm 4).
Measured: baseline, 3 months, 8 months
Change in diastolic blood pressure
The change office diastolic blood pressure (mmHg) from baseline to follow-up at 3 months and 8 months will be calculated and compared across randomization arms (comparing Arm 1 vs. Arm 2 and Arm 3 vs. Arm 4).
Measured: baseline, 3 months, 8 months
Mean systolic blood pressure
Mean office systolic blood pressure (mmHg) at 3 months (mid-trial) and 8-months of follow-up (end of trial) calculated and compared across randomization arms (comparing Arm 1 vs. Arm 2 and Arm 3 vs. Arm 4).
Measured: baseline, 3 months, 8 months
Mean diastolic blood pressure
Mean office diastolic blood pressure (mmHg) at 3 months (mid-trial) and 8-months of follow-up (end of trial) calculated and compared across randomization arms (comparing Arm 1 vs. Arm 2 and Arm 3 vs. Arm 4).
Measured: baseline, 3 months, 8 months
Acceptability of Implementation
Acceptability will be measured by questionnaire. Items are adapted from the validated Acceptability of Implementation Measure (AIM) and are rated on a 5-point Likert scale ranging from 1 to 5, with 1 indicating "Completely disagree" and 5 indicating "Completely agree." Higher scores indicate better intervention acceptability. The items are analyzed individually and not summed to a total score.
Measured: 8 months
Feasibility of Implementation
Feasibility will be measured by questionnaire using items adapted from the validated Feasibility of Implementation Measure (FIM) and rated on a 5-point Likert scale ranging from 1 to 5, with 1 indicating "Completely disagree" and 5 indicating "Completely agree." Higher scores indicate better feasibility. The items are analyzed individually and not summed to a total score.
Measured: 8 months
Appropriateness of Implementation
Appropriateness will be measured by questionnaire. Items are adapted from the validated Implementation Appropriateness Measure (IAM) and are rated on a 5-point Likert scale ranging from 1 to 5, with 1 indicating "Completely disagree" and 5 indicating "Completely agree." Higher scores indicate better appropriateness. The items are analyzed individually and not summed to a total score.
Measured: 8 months
Satisfaction with Intervention
Satisfaction with the intervention components will be measured by questionnaire. Participants will rate their satisfaction with intervention by indicating how likely they are to recommend it to others on a 10-point scale with higher scores indicating greater satisfaction (net promoter score). They will also be asked to rate the quality of the intervention as poor, fair, good, very good, or excellent. The items are analyzed individually and not summed to a total score.
Measured: 8 months
Food Insecurity
The USDA Household Food Security Survey (FSSM-6 item) will be administered at baseline, 3 months, and 8 months. The scores range from 0-6 such that a score of 0-1 indicates high or marginal food security, 2-4 indicates low food security, and 5-6 indicates very low food security. Changes in the score from baseline to follow up at 3 month and 8 months will be evaluated. In addition differences in mean scores will be compared across the randomization arms (comparing Arm 1 vs. Arm 2 and Arm 3 vs. Arm 4).
Measured: baseline, 3 month, 8 months
Nutrition Insecurity
The Gretchen Swanson 4-item nutrition screener will be administered at baseline, 3 months, and 8 months (score range: 0-4 with higher scores indicating higher nutrition security). Changes in the score from baseline to follow up at 3 month and 8 months will be evaluated. In addition differences in mean scores will be compared across the randomization arms (comparing Arm 1 vs. Arm 2 and Arm 3 vs. Arm 4).
Measured: baseline, 3 months, 8 months
Sleep Health
Sleep duration and quality will be measured using the Pittsburgh Sleep Quality Index (PSQI, score range: 0-21). Changes in self-reported habitual hours of sleep and the PSQI score from baseline to follow up at 3 month and 8 months will be evaluated. In addition differences in mean sleep duration and PSQI scores will be compared across the randomization arms (comparing Arm 1 vs. Arm 2 and Arm 3 vs. Arm 4).
Measured: baseline, 3 month, 8 months
Self-rated health
Participant will rate their health as excellent, very good, good, fair, or poor at baseline, 3 months, and 8 months. Changes in self-rated health from baseline to follow up at 3 month and 8 months as well as the differences in mean self-rated health will be compared across the randomization arms (comparing Arm 1 vs. Arm 2 and Arm 3 vs. Arm 4).
Measured: baseline, 3 months, 8 months
General Health Status
The EuroQoL 5-Dimension 5-Level (EQ-5D-5L) will be used to measure general health status and quality of life. This will be captured based on five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression, and each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. Based on the participant's response for reach dimension they will receive a 1-digit number, and the digits for the five dimensions will be combined into a 5-digit number that describes the patient's health state. This study will evaluate changes in this measure from baseline to follow up at 3 month and 8 months. In addition, differences in mean scores will be compared across the randomization arms (comparing Arm 1 vs. Arm 2 and Arm 3 vs. Arm 4).
Measured: baseline, 3 month, 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2024
- Study start28 Aug 2024
- Primary completion5 Jun 2026
- Study completion5 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diet, HealthyStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 176 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Responsible party
- Principal investigator, Nour Makarem, PhD, Columbia University
- Investigators
- Nour Makarem, PhD, FAHA, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06550297
- Sponsor's protocol ID
- AAAV0681
- Other IDs
- 24FIM1267661
- Acronym
- MTM4CVH
- Status last verified
- Aug 2026
- First submitted
- 9 Aug 2024
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be shared de-identified and in aggregate, consistent with the American Hospital Association Healthcare x Food requirements.
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing, Culturally Adapting, and Expanding Medically Tailored Meals Programs to Address Cardiometabolic Multi-morbidity
- ClinicalTrials.gov ID
- NCT06550297
- Acronym / sponsor ID
- MTM4CVH / AAAV0681
- Conditions
- Diet, Healthy, HbA1c, Blood Pressure
- Keywords
- Medically Tailored Meals, Type 2 Diabetes, High Blood Pressure, Multiple Cardiometabolic Morbidity, Food is Medicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 176 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- American Heart Association
- Study start
- 28 Aug 2024 (actual)
- Primary completion
- 5 Jun 2026 (actual)
- Study completion
- 5 Jun 2026 (actual)
- First posted
- 13 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized clinical trial (RCT) will investigate novel approaches to enhance effectiveness, engagement, reach, and cost-effectiveness of medically tailored meals (MTM) programs for promoting cardiovascular health, focusing on economically disadvantaged New York City neighborhoods with a disparate burden of multiple cardiometabolic diseases. The main questions the RCT aims to answer are:
- Does enhancing MTM programs, with culturally relevant cardiovascular health curriculum (including educational sessions on heart health, healthy diet, cooking demonstrations, recipes, gift bags with healthy ingredients and fresh produce, and addressing social needs) enhance program engagement and effectiveness in improving short-term healthy eating behaviors and clinical outcomes (HbA1c and blood pressure) among individuals with type 2 diabetes and elevated to high blood pressure who currently qualify for MTM programs?
- Is the MTM program coupled with the cardiovascular health curriculum effective for improving healthy eating behaviors and clinical outcomes (HbA1c and blood pressure) among individuals with type 2 diabetes and elevated to high blood pressure who do not currently qualify for MTM programs and is a gradual reduction of MTM dosing an effective and sustainable approach for expanding reach of these programs?
To answer question 1, 66 participants with type 2 diabetes and elevated to high blood pressure who currently qualify for MTM programs will be randomized into a group that receives the standard MTM program (10 MTMs/week for 8 months) or a group that receives the standard program plus the cardiovascular health curriculum.
To answer question 2, 110 participants with type 2 diabetes and elevated to high blood pressure who do not currently qualify for MTM programs (due to not having advanced disease with complications) will be randomized into a group that receives the standard MTM program (10 MTMs/week for 8 months) plus the cardiovascular health curriculum or a group that receives standard MTM program for the first 3 months followed by a gradual reduction in dosing of the MTMs by 50% over the remaining 5 months plus the CVH curriculum.
All participants will have their HbA1c and blood pressure measured and complete questionnaires about their diet quality, health and lifestyle behaviors, and program engagement and implementation at baseline, 3 months, and 8 months.
Detailed description
Medically tailored meals (MTMs) represent an integral in-kind intervention of the Food Is Medicine (FIM) initiative aimed at providing healthy food in a way that is integrated with the health care sector to prevent and manage chronic disease. MTMs are a promising approach to address diet-related cardiovascular inequities, because they collectively address food and nutrition insecurity, severe illness or chronic cardiometabolic disease, and challenges with activities of daily living such as shopping for or preparing meals in those with complex medical conditions. However, additional research is needed to determine how MTM programs could be enhanced to become more culturally and contextually responsive, increase engagement with these programs, enhance their effectiveness and sustainability, and expand their reach.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Cohort A (type 2 diabetes patients who currently qualify for MTMs) Active Comparator | Active comparator | Behavioral: Medically Tailored Meals and Nutritional CounselingParticipants in this arm are type 2 diabetes patients with hypertension or elevated blood pressure who currently qualify for medically tailored meals (MTMs). This arm will receive God's Love We Deliver's current MTM program, which consists of 10 home-delivered MTMs per week and nutritional counseling by a Registered Dietitian Nutritionist for an 8-month period. |
| Arm 2: Cohort A (type 2 diabetes patients who currently qualify for MTMs) Intervention | Experimental | Behavioral: Medically Tailored Meals and Nutritional Counseling, Behavioral: Cardiovascular Health Promotion Educational ProgramParticipants in this arm are type 2 diabetes patients with hypertension or elevated blood pressure who currently qualify for medically tailored meals (MTMs). This arm will receive God's Love We Deliver's current MTM program, which consists of 10 home-delivered MTMs per week and nutritional counseling by a Registered Dietitian Nutritionist for an 8-month period (same as Arm 1). In addition, they will receive a culturally and contextually tailored cardiovascular health promotion program that consists of didactic sessions focused on lifestyle change and the American Heart Association's Life's Essential 8 framework, setting weekly specific, measurable, attainable, realistic, and timely (S.M.A.R.T.) goals for health behavior modification, group coaching, cooking demonstrations, recipes and gift bags with healthy ingredients, and addressing social needs. |
| Arm 3: Cohort B (type 2 diabetes patients who do not currently qualify for MTMs) Active Comparator | Active comparator | Behavioral: Medically Tailored Meals and Nutritional Counseling, Behavioral: Cardiovascular Health Promotion Educational ProgramParticipants in this arm are type 2 diabetes patients with hypertension or elevated blood pressure who do not currently qualify for medically tailored meals (MTM) programs. This arm will receive God's Love We Deliver's current MTM program, which consists of 10 home-delivered MTMs per week and nutritional counseling by a Registered Dietitian Nutritionist for an 8-month period. In addition, they will receive a culturally and contextually tailored cardiovascular health promotion program that consists of didactic sessions focused on lifestyle change and the American Heart Association's Life's Essential 8 framework, setting weekly specific, measurable, attainable, realistic, and timely (S.M.A.R.T.) goals for health behavior modification, group coaching, cooking demonstrations, recipes and gift bags with healthy ingredients, and addressing social needs. |
| Arm 4: Cohort B (type 2 diabetes patients who do not currently qualify for MTMs) Intervention | Experimental | Behavioral: Medically Tailored Meals and Nutritional Counseling, Behavioral: Cardiovascular Health Promotion Educational ProgramParticipants in this arm are type 2 diabetes patients with hypertension or elevated blood pressure who do not currently qualify for medically tailored meals (MTM) programs. This arm will receive the MTM program and nutritional counseling by a Registered Dietitian Nutritionist for an 8-month period but with a distinct MTM dosing schedule. They will receive the regular MTM schedule of 10 MTMs/week for the first 3 months of the intervention. After this initial period, MTM dosing will be gradually reduced by 1 MTM each month to a target schedule of 5 MTMs/week in the final month of the intervention. In addition, they will also receive the same culturally and contextually tailored cardiovascular health promotion program as Arms 2 and 3. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Qualifying type 2 diabetes diagnosis (typically physician referred to the program due to more advanced disease with uncontrolled diabetes and complications)
- Hypertension diagnosis (systolic blood pressure greater than or equal to 130 mmHg and/or diastolic blood pressure greater than or equal to 80 mmHg) or elevated blood pressure (defined as systolic blood pressure greater than or equal to 120 mmHg)
- Type 2 diabetes diagnosis (physician diagnosed or HbA1c greater than or equal to 6.5% or diabetes medication use)
- Hypertension diagnosis (systolic blood pressure greater than or equal to 130 mmHg and/or diastolic blood pressure greater than or equal to 80 mmHg or physician diagnosis or hypertension medication use) or elevated blood pressure (defined as systolic blood pressure greater than or equal to 120 mmHg)
Key exclusion criteria (15 listed)
- Cancer diagnosis
- Undergoing cancer treatment
- Non-English or non-Spanish speaking
- Not cognitively able to complete study requirements
- Severe psychiatric disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medically Tailored Meals and Nutritional CounselingGod's Love We Deliver's current MTM program, which consists of weekly home-delivered MTMs and nutritional counseling by a Registered Dietitian Nutritionist for an 8-month period. The Food is Medicine Coalition Clinical Committee establishes and regularly updates the MTM Nutrition Standards, which catalogue the nutrition quality of this evidence-based intervention. Arms 1-3 will receive 10 MTMs per week for 8 months. Arm 4 will receive a distinct dosing down approach as follows: 10 MTMs/week in months 1-3, 9 MTMs/week in month 4, 8 MTMs/week in month 5, 7 MTMs/week in month 6, 6 MTMs/week in month 7, and 5 MTMs/week in month 8. | Behavioural | Arm 1: Cohort A (type 2 diabetes patients who currently qualify for MTMs) Active Comparator, Arm 2: Cohort A (type 2 diabetes patients who currently qualify for MTMs) Intervention, Arm 3: Cohort B (type 2 diabetes patients who do not currently qualify for MTMs) Active Comparator, Arm 4: Cohort B (type 2 diabetes patients who do not currently qualify for MTMs) Intervention |
| Cardiovascular Health Promotion Educational ProgramCulturally and contextually tailored cardiovascular health promotion program that consists of didactic sessions focused on lifestyle change and the American Heart Association's Life's Essential 8 framework, setting weekly specific, measurable, attainable, realistic, and timely (S.M.A.R.T.) goals for health behavior modification, group coaching, cooking demonstrations, recipes and gift bags with healthy ingredients and fresh produce, and addressing social needs. | Behavioural | Arm 2: Cohort A (type 2 diabetes patients who currently qualify for MTMs) Intervention, Arm 3: Cohort B (type 2 diabetes patients who do not currently qualify for MTMs) Active Comparator, Arm 4: Cohort B (type 2 diabetes patients who do not currently qualify for MTMs) Intervention |
Primary outcome
Change in Diet Quality
Time frame: baseline, 3 months, 8 months (primary endpoint)
The Mediterranean Eating Pattern for Americans (MEPA) scale, which captures adherence to a heart healthy dietary pattern, will be used to assess diet quality. The MEPA score ranges from 0-16 with higher scores indicating better diet quality. The change in MEPA scores from baseline to 8 months will be calculated and compared across randomization arms (comparing Arm 1 vs. Arm 2 and Arm 3 vs. Arm 4).
Change in HbA1c
Time frame: baseline, 3 months, 8 months (primary endpoint)
A fast and accurate HbA1c fingerstick test will assess changes in glycemic control from baseline to 3 months and 8 months (comparing Arm 1 vs. Arm 2 and Arm 3 vs. Arm 4).
Change in systolic blood pressure
Time frame: baseline, 3 months, 8 months (primary endpoint)
The change office systolic blood pressure (mmHg) from baseline to follow-up at 3 months and 8 months will be calculated and compared across randomization arms (comparing Arm 1 vs. Arm 2 and Arm 3 vs. Arm 4).
14 secondary outcomes
Mean Diet Quality
Time frame: baseline, 3 months, 8 months
Mean HbA1c
Time frame: baseline, 3 months, 8 months
Change in diastolic blood pressure
Time frame: baseline, 3 months, 8 months
Mean systolic blood pressure
Time frame: baseline, 3 months, 8 months
Mean diastolic blood pressure
Time frame: baseline, 3 months, 8 months
Acceptability of Implementation
Time frame: 8 months
Feasibility of Implementation
Time frame: 8 months
Appropriateness of Implementation
Time frame: 8 months
Satisfaction with Intervention
Time frame: 8 months
Food Insecurity
Time frame: baseline, 3 month, 8 months
Nutrition Insecurity
Time frame: baseline, 3 months, 8 months
Sleep Health
Time frame: baseline, 3 month, 8 months
Self-rated health
Time frame: baseline, 3 months, 8 months
General Health Status
Time frame: baseline, 3 month, 8 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Individual participant dataSharing planned: No. Data will be shared de-identified and in aggregate, consistent with the American Hospital Association Healthcare x Food requirements.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nour Makarem, PhD, FAHA principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medically Tailored Meals and Nutritional Counseling and Cardiovascular Health Promotion Educational Program in people with Diet, Healthy and HbA1c, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Diet Quality (time frame: baseline, 3 months, 8 months (primary endpoint)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.